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OpenTrials
Completed

NCT Number: NCT00072852

Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Capital Federal, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with diagnosis of primary adenocarcinoma of the breast
  • Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent
  • At least one measurable lesion >20mm (or >10 mm with spiral CT scan)
  • Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting
  • Women at least 18 years old, with performance status 0-2

Exclusion criteria

  • Prior treatment with another topoisomerase I inhibitor
  • Current enrollment in another clinical trial

Treatment and study plan

Irinotecan

Drug

Primary outcomes

  1. To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Nov 13, 2003
Registry last updated
Oct 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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